Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020232
Company: ACTAVIS LABS UT INC
Company: ACTAVIS LABS UT INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FIORICET W/ CODEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/30/1992 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020232s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020232Orig1s045ltr.pdf | |
| 10/07/2019 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020232s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020232Orig1s044ltr.pdf | |
| 09/18/2018 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020232s042s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020232Orig1s042s043ltr.pdf | |
| 09/18/2018 | SUPPL-42 | REMS - PROPOSAL - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020232s042s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020232Orig1s042s043ltr.pdf | |
| 08/29/2017 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020232s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020232Orig1s041ltr.pdf | |
| 12/16/2016 | SUPPL-40 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020232s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020232Orig1s040ltr.pdf | |
| 07/31/2015 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/2015 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/05/2014 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/2013 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020232Orig1s036ltr.pdf | |
| 05/09/2013 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020232Orig1s035ltr.pdf | |
| 06/22/2011 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020232s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020232s033ltr.pdf | |
| 03/21/2008 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020232s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020232s021ltr.pdf | |
| 04/26/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/03/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/22/2001 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/04/2001 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/03/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1999 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/20/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/08/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/29/1994 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/01/1992 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020232s045lbl.pdf | |
| 10/07/2019 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020232s044lbl.pdf | |
| 09/18/2018 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020232s042s043lbl.pdf | |
| 09/18/2018 | SUPPL-42 | REMS - PROPOSAL - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020232s042s043lbl.pdf | |
| 08/29/2017 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020232s041lbl.pdf | |
| 12/16/2016 | SUPPL-40 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020232s040lbl.pdf | |
| 12/16/2016 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020232s040lbl.pdf | |
| 12/16/2016 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020232s040lbl.pdf | |
| 10/18/2013 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s036lbl.pdf | |
| 05/09/2013 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s035lbl.pdf | |
| 06/22/2011 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020232s033lbl.pdf | |
| 03/21/2008 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020232s021lbl.pdf |
FIORICET W/ CODEINE
CAPSULE;ORAL; 325MG;50MG;40MG;30MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE;ORAL | Prescription | No | AB | 215138 | HIKMA |
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE;ORAL | Prescription | No | AB | 076560 | LGM PHARMA |
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE;ORAL | Prescription | No | AB | 075929 | NOSTRUM LABS INC |
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE;ORAL | Prescription | No | AB | 204649 | STRIDES PHARMA |
| FIORICET W/ CODEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE;ORAL | Prescription | Yes | AB | 020232 | ACTAVIS LABS UT INC |